Status: Final Organizations: U.S. Food and Drug Administration, Center for Devices and Radiological Health Date: January 2000 Target Audience: Makers of spinal devices who wish to apply to the FDA for an Investigational Device Exemption (IDE) Laws and Regulations...

Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application Status: Final Date: February 1997 Released by: Center for Drugs and Biologics, Federal Drug Administration, Department of Health and Human Services Target...

Guidance for Industry. M4: Organization of the Common Technical Document (CTD) Status: Final Date: August 2001 Organizations: International Conference on Harmonisation (ICH) United States Department of Health and Human Services United States Food and Drug...

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